Samsung is taking its wireless earbuds beyond music and calls. The company has announced that its Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration (FDA), allowing compatible Galaxy Buds to function as over-the-counter (OTC) hearing aids for eligible adults.
The feature is designed for people aged 18 and above who experience perceived mild to moderate hearing loss. Samsung says the functionality is intended to make hearing support more accessible without requiring a prescription or a clinic visit.
Galaxy Buds Can Now Offer Personalised Hearing Support
Samsung’s new hearing solution combines two main functions: Hearing Test and Hearing Aid.
The Hearing Test is built directly into the Galaxy Buds experience. Users can complete a self-administered hearing assessment in around five minutes, with each ear tested separately using pure-tone audiometry.
Based on the results, the system creates an audiogram and identifies the user’s level of hearing loss. Samsung says the assessment can classify hearing as normal or as mild, moderate, severe or profound hearing loss.
Hearing Aid Feature Adjusts Sound Based on the User
After completing the hearing test, the Hearing Aid feature can personalise sound amplification according to the user’s hearing profile.
The technology is designed to make certain sounds easier to hear, including higher-frequency sounds, nearby whispers and voices coming from a distance. Samsung has also incorporated features such as noise elimination and beamforming, which can help focus on sounds coming from the front while reducing unwanted background noise.
Samsung says the compatible earbuds use the NAL-NL2 fitting approach, a formula recognised for hearing-aid fitting.
Which Galaxy Buds Will Support the Feature?
The FDA-cleared functionality will initially be available on:
- Galaxy Buds3 Pro
- Galaxy Buds4 Pro
Samsung says the Hearing Aid and Hearing Test features are expected to roll out in the fourth quarter of 2026 in the U.S. and selected markets where regulatory approval is available.
The feature is not being announced as a universal upgrade for every Galaxy Buds model.
Samsung Has Been Working on Hearing Technology for Years
The new FDA clearance builds on Samsung’s earlier work in hearing-related technology. The company introduced a Personal Sound Amplification Product (PSAP) feature with the Galaxy Buds+ in 2020.
Samsung says that technology was clinically validated in 2021. For its newer OTC hearing solution, the company worked with the National Acoustic Laboratories (NAL) and Samsung Medical Center, with clinical validation studies conducted at several institutions, including Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
Hearing Data Can Also Be Viewed in Samsung Health
Samsung is also integrating hearing-related information into its wider health ecosystem. Users can access information such as hearing-test results and noise-exposure data through the Samsung Health app.
This gives Samsung an opportunity to connect hearing-related insights with other health and wellness information already available through its ecosystem.
Not a Replacement for Professional Medical Care
Although the Galaxy Buds feature is FDA-cleared as an OTC hearing aid for its intended use, Samsung states that it is meant for adults with perceived mild to moderate hearing loss.
The company also notes that the feature is not a substitute for professional diagnosis or treatment by a qualified healthcare professional. Availability can also differ depending on the market, device model and paired device.
What This Means for Galaxy Buds Users
The FDA clearance represents a significant expansion of what consumer earbuds can do. Instead of being limited to entertainment, communication and noise cancellation, compatible Galaxy Buds will be able to provide personalised hearing assistance for eligible users.
Samsung’s move also puts its premium earbuds in closer competition with other consumer audio products that have entered the hearing-health space.
With the rollout planned for late 2026, the Galaxy Buds3 Pro and Galaxy Buds4 Pro could become useful options for people looking for a more accessible form of hearing support alongside their everyday wireless earbuds.
